The use of pre-packed stackable chromatography column modules or cartridges has a potential to increase flexibility in pilot and process scale bio-manufacturing. The flexibility arises from the ability to build a larger system for the required capacity and contaminant clearance from a number of standardized modules. However, a number of issues have to be addressed in order to provide such a system with full flexibility.
The binding capacity of the system depends on the bed volume and in order to increase capacity without affecting the back pressure at realistic residence times, it is desirable to be able to run chromatography column modules in parallel. On the other hand, for some separations a larger bed height may be required to achieve the required contaminant clearance. This leads to a need for serial coupling of chromatography column modules. Hence, it is desirable to have full flexibility with respect to serial and/or parallel coupling of the modules. It should be possible to provide an all parallel stack as well as an all serial stack and intermediate configurations, typically involving parallel coupling of several serial trains of chromatography column modules.
FR2681138 discloses a stack of chromatography column modules, but this construction requires a plurality of external tubing connections between the modules and is not suitable for large scale use. WO2011152788 also discloses a stack of chromatography column modules but does not provide details for the flexible connection of standardized modules in different configurations. These documents are hereby incorporated by reference in their entireties.
Accordingly there is a need for a chromatography column module system allowing flexible connection in parallel, serial and mixed mode operations without cumbersome external tubing connections. There is also a need for standardized components for assembling the system and for a convenient assembly method.